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Table 1 Baseline patient demographics and characteristics

From: Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial

  Safety/PK component POC component  
  Maraviroc 150 mg BID (n= 8) Maraviroc 300 mg BID (n= 8) Placebo (n= 33) Maraviroc 300 mg BID (n= 77) Pvaluea
Female, number (percentage) 4 (50.0) 5 (62.5) 22 (66.7) 71 (92.2) 0.0014
Age in years      
   Mean (SD) 58.5 (7.8) 56.6 (5.9) 53.4 (11.1) 53.6 (12.1) 0.9274
   Range 44-67 46-63 34-76 20-81 -
Race, number (percentage)      -
   White 8 (100.0) 8 (100.0) 21 (63.6) 51 (66.2)  
   Black 0 0 0 3 (3.9)  
   Asian 0 0 5 (15.2) 7 (9.1)  
   Other 0 0 7 (21.2) 16 (20.8)  
Weight in kg, mean (SD) 90.9 (30.4) 88.9 (13.9) 72.7 (16.9) 70.5 (15.4) 0.5173
Height in cm, mean (SD) 164.5 (11.1) 167.4 (4.8) 162.0 (9.7) 159.8 (7.6) 0.2057
BMI in kg/m2, mean (SD) 33.3 (10.2) 31.6 (4.0) 27.6 (5.5) 27.5 (5.4) 0.9670
Duration from first diagnosisb      0.9817
   Mean in years 11.0 11.9 7.8 7.9  
   Range in years 3.0-22.3 2.5-29.0 0.6-32.0 0.4-40.0  
ACR components, mean (SD)c      
   Tender/painful joint count - - 17.5 (6.6) 16.4 (7.3) 0.3565
   Swollen joint count - - 12.8 (5.9) 11.5 (4.6) 0.2062
   Patient's assessment of arthritis pain - - 57.9 (26.0) 59.3 (20.6) 0.6375
   Patient's global assessment of arthritis - - 61.8 (26.1) 61.3 (21.2) 0.8932
   Physician's global assessment of arthritis - - 3.5 (0.7) 3.5 (0.7) 0.7926
   HAQ-DI - - 1.7 (0.7) 1.7 (0.6) 0.8405
   CRP - - 17.4 (19.0) 14.3 (13.2) 0.6946
DAS28-4 (CRP)c - - 6.0 (0.9) 5.8 (0.8) 0.4554
  1. aTwo-sample t test comparison for proof-of-concept (POC) component demographics. bTo day 1 of study. cAmerican College of Rheumatology (ACR) components and DAS28-4 (CRP) were not assessed at baseline for the safety/pharmacokinetic (PK) component. BID, twice daily; BMI, body mass index; CRP, C-reactive protein; DAS28-4 (CRP), disease activity score, 28-joint count, using C-reactive protein; HAQ-DI, health assessment questionnaire-disease index; SD, standard deviation.